Anspach Helix™ L-2SB-HX-G1

GUDID 00845384018131

ANSPACH HELIX™ 2 mm Fluted Ball, Standard Length

Anspach Effort, The

Cranial bur, single-use

• Primary Device ID: 00845384018131
• NIH Device Record Key: edad92c2-7a0b-4852-b0d5-a03a8a133919
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anspach Helix™
• Version Model Number: L-2SB-HX-G1
• Catalog Number: L-2SB-HX-G1
• Company DUNS: 079116867
• Company Name: Anspach Effort, The
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845384018131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183545

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-19
• Device Publish Date: 2019-12-11

On-Brand Devices [Anspach Helix™]

• 00845384018247: ANSPACH HELIX™ 7 mm Fluted Ball
• 00845384018230: ANSPACH HELIX™ 6 mm Fluted Ball
• 00845384018223: ANSPACH HELIX™ 5 mm Fluted Ball
• 00845384018216: ANSPACH HELIX™ 4 mm Fluted Ball
• 00845384018186: ANSPACH HELIX™ 3 mm Fluted Ball, Extended Length
• 00845384018179: ANSPACH HELIX™ 3 mm Fluted Ball, Standard Length
• 00845384018148: ANSPACH HELIX™ 2 mm Fluted Ball, Extended Length
• 00845384018131: ANSPACH HELIX™ 2 mm Fluted Ball, Standard Length
• 00845384018070: ANSPACH HELIX™ 7 mm Fluted Ball
• 00845384018063: ANSPACH HELIX™ 6 mm Fluted Ball
• 00845384018056: ANSPACH HELIX™ 5 mm Fluted Ball
• 00845384018049: ANSPACH HELIX™ 4 mm Fluted Ball
• 00845384018018: ANSPACH HELIX™ 3 mm Fluted Ball, Extended Length
• 00845384018001: ANSPACH HELIX™ 3 mm Fluted Ball, Standard Length
• 00845384017974: ANSPACH HELIX™ 2 mm Fluted Ball, Extended Length
• 00845384017967: ANSPACH HELIX™ 2 mm Fluted Ball, Standard Length
• 00845384017905: ANSPACH HELIX™ 7 mm Fluted Ball
• 00845384017899: ANSPACH HELIX™ 6 mm Fluted Ball
• 00845384017882: ANSPACH HELIX™ 5 mm Fluted Ball
• 00845384017875: ANSPACH HELIX™ 4 mm Fluted Ball
• 00845384017868: ANSPACH HELIX™ 3.5 mm Fluted Ball, Extended Length
• 00845384017851: ANSPACH HELIX™ 3.5 mm Fluted Ball, Standard Length
• 00845384017844: ANSPACH HELIX™ 3 mm Fluted Ball, Extended Length
• 00845384017837: ANSPACH HELIX™ 3 mm Fluted Ball, Standard Length
• 00845384017820: ANSPACH HELIX™ 2.5 mm Fluted Ball, Extended Length